Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers

National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP)

Status: Completed

Conditions: Long-term Effects Secondary to Cancer Therapy in Adults; Psychosocial Effects of Cancer and Its Treatment; Fatigue; Pain; Colorectal Cancer

Treatments: Other: Telephone interview

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT00410579

NSABP LTS-01

CDR0000494640 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Learning about quality of life, symptoms, and health behaviors in colorectal cancer survivors may help to determine the long-term effects of colon and rectal cancer treatments and may help to improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors of colon and rectal cancers.

Full description

OBJECTIVES:

• Characterize 3 separate types of patient-reported outcomes (quality of life [e.g., generic and disease-specific], functional outcomes [e.g., bowel and sexual function and activities of daily living], and clinical symptoms [e.g., pain, fatigue]) in long-term (5+ years) survivors of colon and rectal cancers in a large national sample recruited from five National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment trials.
• Explore the degree to which patient-reported outcomes are impacted by individual characteristics (e.g., specific predisposing factors, enabling resources, and need), by health behaviors (e.g., use of services for cancer-related and non-cancer-related issues), and, when appropriate, by the specific treatments that were received.
• Examine patient-reported outcomes prior to randomization and treatment, 1 year after treatment, and in long-term follow up > 5 years after diagnosis in patients with colon cancer treated with adjuvant chemotherapy on protocols NSABP C-06 or NSABP C-07.

OUTLINE: This is a cohort, single-group, multicenter study.

Patients complete a one-time, computer-assisted telephone interview assessing their overall quality of life (QOL), disease-specific QOL, function and symptoms (including pain and fatigue), use of healthcare services, prevalence and severity of comorbidity, and demographics.

PROJECTED ACCRUAL: A total of 1,167 patients will be accrued for this study.

Enrollment: 744 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Prior diagnosis of colon or rectal cancer

• At least 5 years since participated in 1 of the following clinical trials:

  • NSABP-R-02
  • NSABP-R-03
  • NSABP-C-05
  • NSABP-C-06
  • NSABP-C-07

PATIENT CHARACTERISTICS:

• Able to speak English

PRIOR CONCURRENT THERAPY:

• As per participation requirements of previous NSABP treatment trials

Trial design

744 participants in 1 patient group

Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07

Description:

Study population to be interviewed comprises patients who were treated at least 5 years ago for colon or rectal cancer in NSABP trials R-02, R-03, C-05, C-06 or C-07

Treatment:

Other: Telephone interview